510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 89 of 1190
FDA device recalls, page 89 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1610-2025Class IIMedline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1609-2025Class IIMedline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model...MEDLINE INDUSTRIES, LP - NorthfieldPAD
Z-1608-2025Class IIMedline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldKKX
Z-1607-2025Class IIMedline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldFQM
Z-1606-2025Class IIMedline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-1605-2025Class IIMedline Convenience kits used for various procedures: 1) NAIL PACK, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldMDM
Z-1604-2025Class IIMedline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-1603-2025Class IIMedline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-1602-2025Class IIRefer to RESMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1601-2025Class IIMedline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-1600-2025Class IIMedline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1599-2025Class IIMedline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-1598-2025Class IIRefer to RESMEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1597-2025Class IIMedline Convenience kits used for various procedures: 1) T A PACK, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1596-2025Class IIMedline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldMMO
Z-1595-2025Class IIMedline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-1594-2025Class IIMedline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1593-2025Class IIMedline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1592-2025Class IIMedline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1591-2025Class IIMedline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1590-2025Class IIMedline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1589-2025Class IIMedline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model...MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-1588-2025Class IIMedline Convenience kits used for various procedures: 1) PAIN PACK, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-1587-2025Class IIMedline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldNXA
Z-1586-2025Class IIMedline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1651-2025Class IIstryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF...TORNIER Inc.JDB
Z-1403-2025Class IIComprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem...Zimmer Orthopedics Manufacturing Limited-GalwayMBF
Z-1423-2025Class IIBaxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUSBaxter Healthcare CorporationFRN
Z-1492-2025Class IITerumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number...Terumo Cardiovascular Systems CorporationDRY
Z-1324-2025Class IISpectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;Philips Medical Systems Nederland B.V.JAK
Z-1491-2025Class IIMonterey AL Implant Inserter; 22mm; Catalog 48019140.Howmedica Osteonics CorpOVD
Z-1490-2025Class IIMonterey AL Implant Inserter; 18/20mm; Catalog 48019130.Howmedica Osteonics CorpOVD
Z-1489-2025Class IIMonterey AL Implant Inserter; 14/16mm; Catalog 48019120.Howmedica Osteonics CorpOVD
Z-1488-2025Class IIMonterey AL Implant Inserter; 10/12mm; Catalog 48019100.Howmedica Osteonics CorpOVD
Z-1501-2025Class IIPhoroptor VRx Digital Refraction System Model Numbers: 16242Reichert, Inc.HKN
Z-1500-2025Class IIPhoroptor VRx Digital Refraction System Model Numbers: 16241Reichert, Inc.HKN
Z-2115-2025Class IIAccess Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850Siemens Healthcare Diagnostics Inc.CDD
Z-1520-2025Class ITandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.QFG
Z-1519-2025Class It:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.QFG
Z-1518-2025Class IIFilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374BioFire Diagnostics, LLCQDS
Z-1433-2025Class IINexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained...Zimmer GmbHJWH
Z-1455-2025Class IIBrand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses...CooperVision, Inc.MVN
Z-1408-2025Class IIPremier Solo Diamond - Large Invented Cone; SKU: 807016C.Premier Dental Products CoEJL
Z-1512-2025Class IHippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF...Q'apel Medical, Inc.NRY
Z-1517-2025Class IIDxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 /...Siemens Healthcare Diagnostics Inc.JJE
Z-1390-2025Class IShiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF...Medtronic, Inc.JOH
Z-1325-2025Class IIBrand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray...Intuitive Surgical, Inc.NAY
Z-1582-2025Class IIVeradius Unity. Product Code 718132. The devices are used for radiological guidance and...Philips North America LLCOWB
Z-1581-2025Class IIZenition 70. Product Code 718133. The devices are used for radiological guidance and...Philips North America LLCOWB
Z-1580-2025Class IIZenition 50. Product Code 718096. The devices are used for radiological guidance and...Philips North America LLCOWB